Phase 2 N=1,379 GR270773 In The Treatment Of Suspected Or Confirmed Gram-Negative Severe Sepsis In Adults
Sepsis
Primary: Percentage of Participants With 28-Day All Cause Mortality — 26.9; 25.8; 31.3 Percentage of participants — p=0.329
Clinical Trial Search
Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
N/A N=500 Rapid Identification and Phenotypic Susceptibility Testing for Gram-Negative Bacteremia
Gram-negative Bacteremia
Primary: Hours to First Antibiotic Modification — 24.7; 19.0 hours — p=0.013
Phase 3 N=152 Study of Cefiderocol (S-649266) or Best Available Therapy for the Treatment of Severe Infections Caused by Carbapenem-resistant Gram-negative Pathogens
Healthcare-associated Pneumonia (HCAP) · Bloodstream Infections (BSI) · Hospital Acquired Pneumonia (HAP)
Primary: Percentage of Participants With Clinical Cure at Test of Cure (TOC) in Participants With HAP/VAP/HCAP or BSI/Sepsis — 50.0; 52.6; 43.5; 42.9 percentage of participants
Phase 3 N=333 Ceftazidime-Avibactam for the Treatment of Infections Due to Ceftazidime Resistant Pathogens
Complicated Urinary Tract Infection · Complicated Intra-abdominal Infection
Primary: Clinical Response at Test of Cure (TOC) in Microbiological Modified Intent-to-treat (mMITT) Analysis Set — 6; 8; 129; 132 Participant
N/A N=121 Procalcitonin-Guided Decision Making to Shorten Antibiotic Therapy in Suspected Neonatal Early-Onset Sepsis
Sepsis
Primary: Antibiotic Treatment for More Than 72 Hours — 33; 55 participants — p=0.002
N/A N=500 Effect of Direct-from-blood Bacterial Testing on Antibiotic Administration and Clinical Outcomes
Bloodstream Infection · Sepsis Bacterial · MRSA Bacteremia
Primary: Time to Last Dose of Intravenous Vancomycin — 19.0; 12.5 time in hours
Phase 3 N=464 Trial for the Treatment of Extensively Drug-Resistant Gram-negative Bacilli (OVERCOME)
Pneumonia · Blood Stream Infection
Primary: Mortality — 92; 78; 122; 133 Participants — p=0.21
Phase 2 N=143 Aerosolized Amikacin and Fosfomycin in Mechanically Ventilated Patients With Gram-negative Pneumonia
Pneumonia, Bacterial
Primary: Change From Baseline in Clinical Pulmonary Infection Score (CPIS) For Each Patient, Value Obtained From a Daily Assessment Over the 10 Day Study Period Was Compared to…
Phase 4 N=103 The Use of Probiotics to Evaluate Colonization With Antimicrobial Resistant Bacteria
Infectious Disease of Digestive Tract
Primary: Number of Participants With Combination of Gastrointestinal Tract Colonization With Multi-drug Resistant Gram-negative Bacteria, C. Difficile and VRE — 8; 8 Participants
Phase 3 N=725 Inhaled Amikacin Solution BAY41-6551 as Adjunctive Therapy in the Treatment of Gram-Negative Pneumonia
Pneumonia, Bacterial
Primary: Number of Participants Surviving Through LFU Visit — 191; 196; 64; 57 Participants — p=0.4263
Phase 4 N=12 Pharmacokinetic/Pharmacodynamic Study of Doripenem in Febrile Neutropenic Patients
Febrile Neutropenia
Primary: Mean (SD) Doripenem Pharmacokinetic Volume of Distribution Parameter in Febrile Neutropenic Patients — 36.7; 49.9; 43.9 Liters
Phase 3 N=16 The Effects of Polymyxin-B Protects on Sepsis Induced Kidney Dysfunction: a Randomized Clinical Trial
Gram-Negative Bacterial Infections · Sepsis
Primary: Number of Participants Not Requiring Renal Replacement Therapy (RRT) — 3; 1 participants
Phase 3 N=115 Safety, Tolerability, Efficacy and Pharmacokinetics of Imipenem/Cilastatin/Relebactam (MK-7655A) in Pediatric Participants With Gram-negative Bacterial Infection (MK-7655A-021)
Suspected or Documented Gram-negative Bacterial Infection
Primary: Percentage of Participants With One or More Adverse Event (AE) — 60.0; 50.0; 64.5; 36.4 Percentage of Participants
Phase 4 N=60 Efficacy and Safety of CAZ-AVI in the Treatment of Infections Due to Carbapenem-resistant G- Pathogens in Chinese Adults
Urinary Tract Infection · Acute Pyelonephritis · Hospital Acquired Pneumonia
Primary: Percentage of Participants With Clinical Cure at Test of Cure (TOC) Visit - Microbiologically Modified Intent-to-Treat (mMITT) Analysis Set — 59.3; 25.9 Percentage of…
Phase 3 N=207 Study to Evaluate the Efficacy and Safety of Intravenous Sulbactam-ETX2514 in the Treatment of Patients With Infections Caused by Acinetobacter Baumannii-calcoaceticus Complex
Acinetobacter Baumannii-calcoaceticus Complex · Hospital-acquired Bacterial Pneumonia · Ventilator-associated Bacterial Pneumonia
Primary: Proportion of Patients With All-Cause Mortality in CRABC m-MITT Population — 12; 20 Participants
Phase 3 N=300 Clinical Study of Cefiderocol (S-649266) for the Treatment of Nosocomial Pneumonia Caused by Gram-negative Pathogens
Healthcare-associated Pneumonia (HCAP) · Hospital Acquired Pneumonia (HAP) · Ventilator Associated Pneumonia (VAP)
Primary: All-cause Mortality Rate at Day 14 — 12.4; 11.6 percentage of participants — p=0.0020
N/A N=260 MICRO Study: Detecting Bacterial Infections Related to Orthopaedic Surgical Implants
Open Reduction and Internal Fixation of Extremity Fractures
Primary: Number of Blood Samples With High Levels of Absorbance Via ELISA for Patients (Greater Than 1.5 Ratio Compared to Control Human Serum) — 48; 53 blood draw samples
N/A N=189 Retrospective Analysis of Real World Use of Ceftazidime-avibactam in the Management of Gram Negative Infections
Gram Negative Infections
Primary: Number of Participants With Clinical Symptom Improvement at Day 3 — 82; 21 Participants
Phase 4 N=2,634 Effect of Antibiotic Choice On ReNal Outcomes (ACORN)
Sepsis · AKI · Neurotoxicity
Primary: Acute Kidney Injury (AKI) Ordinal Scale — 910; 952; 86; 100 Participants
Phase 3 N=422 A Study to Determine the Efficacy, Safety and Tolerability of Aztreonam-Avibactam (ATM-AVI) ± Metronidazole (MTZ) Versus Meropenem (MER) ± Colistin (COL) for the Treatment of Serious Infections Due to Gram Negative Bacteria.
Complicated Intra-abdominal Infection · Hosptial Acquired Pneumonia · Ventilator Associated Pneumonia
Primary: Percentage of Participants With Clinical Cure at Test of Cure (TOC) Visit: Intent-To-Treat (ITT) Analysis Set — 68.4; 65.7 Percentage of participants
N/A N=22 Piperacillin PK Analysis in Severe Sepsis Patients
Sepsis · Severe Sepsis
Primary: 100% f T>MIC: Free Piperacillin Concentration Maintained Above the MIC Throughout the Dosing Interval. — 4 participants
N/A N=2,032 Study on Cefotaxime and Sulbactam Sodium for Injection (2:1) for Treatment of Respiratory and Urinary Tract Infection
Respiratory Tract Infections · Urinary Tract Infections
Primary: Number of Participants With Adverse Events — 10; 4; 6; 10 Participants — p=0.05
N/A N=2,124 Detection of Microorganisms and Antibiotic Resistance Genes Using the Curetis Unyvero LRT55 Application
Pneumonia
Primary: Clinical Sensitivity and Specificity for Microorganism Detection as Compared to Routine Microbiology and Other Reference Methods Including PCR and Sequencing — 91.4…
Phase 4 N=21 Population Pharmacokinetics and Safety of Intravenous Ceftolozane/Tazobactam in Adult Cystic Fibrosis Patients
Cystic Fibrosis · Cystic Fibrosis Pulmonary Exacerbation · Pseudomonas Aeruginosa Infection
Primary: Ceftolozane Clearance — 4.76 Liters per hour
N/A N=271 Impact of a Procalcitonin Testing and Treatment Algorithm on Antibiotic Use and Outcomes in the Pediatric Intensive Care Unit
Sepsis · Procalcitonin · Antimicrobial Stewardship
Primary: Days of Antibiotic Therapy in the First 14 Days Following Randomization — 7.6; 6.6 days
Phase 3 N=68 Group B Streptococcus Response After Probiotic Exposure
Group B Strep Infection
Primary: GBS Culture Result (Positive Versus Negative) — 3; 6; 18; 19 Participants
Phase 2 N=94 Inulin for Infections in the Intensive Care Unit
Antibiotic Resistant Infection · Nosocomial Infection · Pathogen Transmission
Primary: Within-individual Change in SCFA Producer Level — -0.0; -1.8; 1.1 percentage of SCFA producers
Phase 4 N=32 Prophylactic Antibiotics in Admitted Cirrhotics
Cirrhosis, Liver
Primary: Infections — 2; 5 Participants
Phase 2 N=370 Gentamicin Intravesical Efficacy for Infection of Urinary Tract
Postoperative Urinary Tract Infection · Pelvic Organ Prolapse · Stress Urinary Incontinence
Primary: Post-operative Urinary Tract Infection — 19; 20 Participants
Phase 2 N=41 Catheter Related - Gram Positive Bloodstream Infections
Bloodstream Infection
Primary: Clinical Response Within 48 Hours — 28 Participants